Tumor, SolidNCT05637034
68Ga-DOTA-F2 PET/CT in Patients With Various Types of Cancer
A study testing 68Ga-DOTA-F2 PET/CT and 18F-FDG in people with Tumor, Solid, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
To evaluate the potential usefulness of 68Ga-DOTA-F2 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer, compared with 18F-FDG PET/CT. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Tumor, Solid
- What is being tested?
- 68Ga-DOTA-F2 PET/CT and 18F-FDG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2022to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is aged 18 years or older
- Signed Informed Consent
- Subject is pathologically confirmed with a malignant tumor
- Subject is judged to be in good general condition by the investigator based on medical history, physical examination including vital signs and clinical laboratory tests, besides the diagnosis of malignant tumor
- Female subjects should be post-menopausal or surgically sterile or using effective contraceptive with the negative pregnancy test
Who cannot join
- Subject has a previous or ongoing recurrent or chronic disease, other than malignant tumor, at high risk to interfere with the evaluation of the trial according to the judgment of the investigator
- Subject with non-malignant lesions;
- Subject with the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
- Subject is potentially pregnant (serum and urinary hCG test will be performed in women where pregnancy is not excluded) or is breast-feeding
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking union medical college hospital
Beijing, Beijing Municipality, 10010
Peipei Wang, MD, 18511395988, wpp199411@163.com
Fang Li, MD, 13901054627, lifang@pumch.cn
About this study
Official title: Clinical Applications of Fibroblast Activation Protein Inhibitor-Based Dimeric Radiotracer 68Ga-DOTA-F2 PET/CT Imaging for Malignant Tumors
To evaluate the potential usefulness of 68Ga-DOTA-F2 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer, compared with 18F-FDG PET/CT.
Read the detailed description
Quinoline-based fibroblast activation protein (FAP) inhibitors (FAPIs; e.g., FAPI-04 and FAPI-46), which have shown promising results in the diagnosis of cancer and various other diseases in recent years, have become the focus of much productive research. Despite this, one major issue is that these FAPI molecules have a relatively short tumor retention time, which may limit their use in targeted radionuclide therapy applications. As a result, 68Ga-DOTA-F2, a novel dimeric FAPI molecule, was developed to increase tracer uptake and retention in tumors for potential therapeutic or theranostic applications. In preclinical study, 68Ga-DOTA-F2 has shown better tumor uptake and longer tumor retention time than 68Ga-FAPI in mouse tumor models. Our study will assess image quality and evaluate the diagnostic performance of 68Ga-DOTA-F2. Patients with histologically confirmed malignant tumors will be prospectively recruited in this study.
- Conditions
- Tumor, Solid
- Being tested
- 68Ga-DOTA-F2 PET/CT and 18F-FDG
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-DOTA-F2 PET/CT and 18F-FDGDiagnostic test
Each subject receive a single intravenous injection of 68Ga-DOTA-F2 and 18F-FDG, and undergo PET/CT imaging within the specified time.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-DOTA-F2 PET/CT and 18F-FDG | Experimental | Each subject receive a single intravenous injection of 68Ga-DOTA-F2 and 18F-FDG, and undergo PET/CT imaging within the specified time. Receives: Diagnostic Test: 68Ga-DOTA-F2 PET/CT and 18F-FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized uptake value (SUV)
Standardized uptake value (SUV) of 68Ga-DOTA-F2 and 18F-FDG for each primary tumor of subject or suspected lymph metastasis
Measured: through study completion, an average of 1 year
Lession detection ability
Lession number detected by 68Ga-DOTA-F2 and 18F-FDG PET/CT
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Sensitivity
The sensitivity of 68Ga-DOTA-F2 PET/CT and 18F-FDG PET/CT
Measured: through study completion, an average of 1 year
Specificity
The specificity of 68Ga-DOTA-F2 PET/CT and 18F-FDG PET/CT
Measured: through study completion, an average of 1 year
Radiation Dosimetry
Mean absorbed radiation doses were estimated using the source and target organ framework. Five patients with different cancers underwent serial 68Ga-DOTA-F2 PET/CT scans at five-time points following radiotracer injection: 5 minutes, 15 minutes, 30 minutes, 1 hour, and 3 hours. The source organs consisted of the kidneys, bladder, liver, heart, spleen, bone marrow, uterus, and body remainder. OLINDA/EXM software was used to fit and integrate the kinetic organ activity data to yield total body and organ time-integrated activity coefficients/residence times and finally organ absorbed doses.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start15 Sep 2022
- Primary completion15 Sep 2023 (estimated)
- Study completion15 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor, SolidStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fang Li, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637034
- Sponsor's protocol ID
- I-22PJ292
- Status last verified
- Nov 2022
- First submitted
- 27 Nov 2022
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Applications of Fibroblast Activation Protein Inhibitor-Based Dimeric Radiotracer 68Ga-DOTA-F2 PET/CT Imaging for Malignant Tumors
- ClinicalTrials.gov ID
- NCT05637034
- Acronym / sponsor ID
- I-22PJ292
- Conditions
- Tumor, Solid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 15 Sep 2023 (estimated)
- Study completion
- 15 Sep 2023 (estimated)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the potential usefulness of 68Ga-DOTA-F2 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer, compared with 18F-FDG PET/CT.
Detailed description
Quinoline-based fibroblast activation protein (FAP) inhibitors (FAPIs; e.g., FAPI-04 and FAPI-46), which have shown promising results in the diagnosis of cancer and various other diseases in recent years, have become the focus of much productive research. Despite this, one major issue is that these FAPI molecules have a relatively short tumor retention time, which may limit their use in targeted radionuclide therapy applications. As a result, 68Ga-DOTA-F2, a novel dimeric FAPI molecule, was developed to increase tracer uptake and retention in tumors for potential therapeutic or theranostic applications. In preclinical study, 68Ga-DOTA-F2 has shown better tumor uptake and longer tumor retention time than 68Ga-FAPI in mouse tumor models. Our study will assess image quality and evaluate the diagnostic performance of 68Ga-DOTA-F2. Patients with histologically confirmed malignant tumors will be prospectively recruited in this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-DOTA-F2 PET/CT and 18F-FDG | Experimental | Diagnostic Test: 68Ga-DOTA-F2 PET/CT and 18F-FDGEach subject receive a single intravenous injection of 68Ga-DOTA-F2 and 18F-FDG, and undergo PET/CT imaging within the specified time. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is aged 18 years or older
- Signed Informed Consent
- Subject is pathologically confirmed with a malignant tumor
- Subject is judged to be in good general condition by the investigator based on medical history, physical examination including vital signs and clinical laboratory tests, besides the diagnosis of malignant tumor
- Female subjects should be post-menopausal or surgically sterile or using effective contraceptive with the negative pregnancy test
Key exclusion criteria (4 listed)
- Subject has a previous or ongoing recurrent or chronic disease, other than malignant tumor, at high risk to interfere with the evaluation of the trial according to the judgment of the investigator
- Subject with non-malignant lesions;
- Subject with the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
- Subject is potentially pregnant (serum and urinary hCG test will be performed in women where pregnancy is not excluded) or is breast-feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-DOTA-F2 PET/CT and 18F-FDGEach subject receive a single intravenous injection of 68Ga-DOTA-F2 and 18F-FDG, and undergo PET/CT imaging within the specified time. | Diagnostic test | 68Ga-DOTA-F2 PET/CT and 18F-FDG |
Primary outcome
Standardized uptake value (SUV)
Time frame: through study completion, an average of 1 year
Standardized uptake value (SUV) of 68Ga-DOTA-F2 and 18F-FDG for each primary tumor of subject or suspected lymph metastasis
Lession detection ability
Time frame: through study completion, an average of 1 year
Lession number detected by 68Ga-DOTA-F2 and 18F-FDG PET/CT
3 secondary outcomes
Sensitivity
Time frame: through study completion, an average of 1 year
Specificity
Time frame: through study completion, an average of 1 year
Radiation Dosimetry
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fang Li, MD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga-DOTA-F2 PET/CT and 18F-FDG in people with Tumor, Solid, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peipei Wang, MD (18511395988, wpp199411@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized uptake value (SUV) (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2022.